His Bundle Pacing Versus Right Ventricular Pacing

Overview

This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)>40%. The primary outcome measure is LVEF.

Full Title of Study: “His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2023

Detailed Description

Monocentric, randomized, double-blind comparative crossover clinical study. Patients with a standard pacing indication with >20% ventricular pacing, with a baseline LVEF >40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.

Interventions

  • Device: His bundle pacing
    • Pacing with capture of the His bundle
  • Device: Right ventricular pacing
    • Pacing from the right ventricular lead (septal or apical)

Arms, Groups and Cohorts

  • Active Comparator: His bundle pacing
    • Pacing programmed from the His bundle lead
  • Placebo Comparator: Right ventricular pacing
    • Pacing programmed from the right ventricular lead

Clinical Trial Outcome Measures

Primary Measures

  • Left ventricular ejection fraction
    • Time Frame: 6 months
    • Assessed by gated Equilibrium Radionuclide Angiography

Secondary Measures

  • Left ventricular peak filling rate (EDV/s)
    • Time Frame: 6 months
    • Assessed by gated Equilibrium Radionuclide Angiography
  • NYHA functional class
    • Time Frame: 6 months
    • Investigator evaluation
  • 6-minute walk test
    • Time Frame: 6 months
    • Investigator evaluation
  • Quality of life measure by SF-36 questionnaire
    • Time Frame: 6 months
    • SF-36 questionnaire; 0-100 score (the higher the score, the better the quality of life)
  • Right ventricular ejection fraction
    • Time Frame: 6 months
    • Assessed by gated Equilibrium Radionuclide Angiography
  • Hospital admission for cardiovascular causes
    • Time Frame: 6 months
    • Number of days of admissions for cardiovascular causes
  • Hospital admission for cardiovascular causes
    • Time Frame: up to 6 months
    • Duration in days of admissions for cardiovascular causes

Participating in This Clinical Trial

Inclusion Criteria

  • Baseline LVEF>40% – Standard pacing indication with >20% VP – Functional His bundle lead with confirmed His capture – Functional right ventricular lead with myocardial capture Exclusion Criteria:

  • Unable to sign an informed consent form

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Geneva
  • Collaborator
    • Elise Bakelants
  • Provider of Information About this Clinical Study
    • Principal Investigator: Haran Burri, MD, Professor – University Hospital, Geneva
  • Overall Official(s)
    • Haran Burri, MD, Principal Investigator, University Hospital, Geneva
  • Overall Contact(s)
    • Haran Burri, MD, +41223727200, haran.burri@hcuge.ch

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